Capecitabine (Xeloda) in Malignant Mesothelioma: A Phase II Study

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven malignant mesothelioma not amenable to
potentially curative radiotherapy or surgery Epithelial, sarcomatoid, or mixed subtype Any
site of origin allowed including, but not limited to, the following: Pleura Peritoneum
Pericardium Tunica vaginalis Measurable disease At least one lesion accurately measured in
at least one dimension Lesion at least 20 mm at largest diameter with conventional
techniques or at least 10 mm with spiral CT scan The following are not considered
measurable disease: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial
effusion Abdominal masses not confirmed and followed by imaging techniques Cystic lesions
Tumor lesions located in a previously irradiated area

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Life expectancy:
Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT
no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: Not
pregnant or nursing Fertile patients must use effective contraception No active second
malignancy except nonmelanomatous skin cancer Not considered an active second malignancy
if: Therapy has been completed Less than 30% risk of relapse according to the physician No
malabsorption syndrome

PRIOR CONCURRENT THERAPY: Biologic therapy: Concurrent epoetin alfa allowed Chemotherapy:
No prior systemic cytotoxic chemotherapy for malignant mesothelioma Prior intrapleural
cytotoxic or sclerosing agents (including bleomycin) allowed No other concurrent
chemotherapy Endocrine therapy: No concurrent hormonal therapy except the following:
Steroids administered for adrenal failure Hormonal therapy administered for nonmalignant
conditions (e.g., insulin for diabetes) Intermittent use of dexamethasone as an antiemetic
Radiotherapy: At least 4 weeks since prior radiotherapy Prior irradiation of symptomatic
lesion allowed if there is other measurable disease outside the radiation port No
concurrent radiotherapy Surgery: At least 2 weeks since prior major surgery Other: No
concurrent leucovorin calcium or folinic acid